External spinal brace

ABSTRACT

In some embodiments, a system and/or method may include an external spinal brace system. The system may include a plurality of support mechanisms including at least first and second support mechanisms. The first support mechanism may be coupled, during use, to the second support mechanism such that the first and second support mechanisms are inhibited from decoupling. In some embodiments, the system may include a coupling system. The coupling system may couple the plurality of support mechanisms to a subject such that the plurality of support mechanisms are positioned, during use, along at least a portion of the subject&#39;s spine. In some embodiments, the external brace system applies a posterior distraction force to the subject.

PRIORITY CLAIM

This application is a continuation of U.S. patent application Ser. No.16/178,855, filed Nov. 2, 2018, which is a continuation of U.S. patentapplication Ser. No. 15/054,917, filed Feb. 26, 2016, now U.S. Pat. No.10,206,805, granted Feb. 19, 2019 and entitled “EXTERNAL SPINAL BRACE”,which claims priority to U.S. Provisional Patent Application No.62/277,287, filed Jan. 11, 2016 and entitled “EXTERNAL SPINAL BRACE”.The content of each of the above applications is hereby incorporated byreference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present disclosure generally relates to correcting spinal disorders.More particularly, the disclosure generally relates to a method andsupport system for treatment of spinal disorders resulting in abnormalcurvature or structure of the human spine.

2. Description of the Relevant Art

Scoliosis is a medical condition in which a person's spinal axis has athree-dimensional deviation. Other disorders associated withabnormalities in posture include, for example, cerebral palsy,scoliosis, paralyses, dystonia, and injuries of the spine and joints.Such disorders may have far-flung consequences for the entiremusculoskeletal system. Effective treatment and rehabilitation of suchproblems require complex, global therapies that take into account andhave an effect on the entire musculoskeletal system.

Several surgical and nonsurgical methods have been tried in an attemptto treat such disorders. Surgical methods which have been used are ingeneral highly invasive and involve, for example, coupling multiplemetal rods to a subject's spine using multiple screws. Such highlyinvasive surgical procedures typically require a long and arduousrecuperation period.

Noninvasive methods are usually more desirable but depending on thecondition being treated have either limited success or require highlyrestrictive and painful external braces. Current rigid braces putexterior forces on the ribs of a subject which in some instances canlead to rib deformities. There are some flexible braces available whichallow more freedom of movement. However, none of the known externalbraces appear to provide a distraction force to the spine andspecifically a posterior distraction force.

Therefore, a system and/or method which facilitate treatment ofstructural disorders of the spine without invasive techniques orunnecessarily restrictive braces would be highly desirable.

SUMMARY

In some embodiments, a system and/or method may include an externalspinal brace system. The system may include a plurality of supportmechanisms including at least first and second support mechanisms. Thefirst support mechanism may be coupled, during use, to the secondsupport mechanism such that the first and second support mechanisms areinhibited from decoupling. In some embodiments, the system may include acoupling system. The coupling system may couple the plurality of supportmechanisms to a subject such that the plurality of support mechanismsare positioned, during use, along at least a portion of the subject'sspine. In some embodiments, the external brace system applies aposterior distraction force to the subject.

In some embodiments, a system and/or method may include an externalspinal brace system. The system may include a plurality of supportmechanisms including at least a first and a second support mechanisms.The first support mechanism may include a first coupling portion and afirst and a second engaging member at a first end of the first supportmechanism. The first support mechanism may include a first couplingopening and a first and second opening at the second end of the firstsupport mechanism. The second end may be opposite to the first end ofthe first support mechanism. The second support mechanism may include asecond coupling portion and a third and a fourth engaging member at athird end of the second support mechanism. The second support mechanismmay include a second coupling opening and a third and fourth opening atthe fourth end of the second support mechanism. The fourth end may beopposite to the third end of the second support mechanism. The firstcoupling portion of the first support mechanism may be positioned,during use, in the second coupling opening of the second supportmechanism. The first and second engaging members of the first supportmechanism may be positioned, during use, in the third and fourthopenings respectively of the second support mechanism. The system mayinclude a coupling system coupling the plurality of support mechanismsto a subject such that the plurality of support mechanisms arepositioned along at least a portion of the subject's spine during use.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present invention may become apparent to those skilledin the art with the benefit of the following detailed description of thepreferred embodiments and upon reference to the accompanying drawings.

FIG. 1 depicts a rear view of a representation of an embodiment of anexternal spinal brace system.

FIG. 2 depicts a front view of a representation of an embodiment of anexternal spinal brace system.

FIG. 3 depicts a rear view of a representation of an embodiment of firstand second support mechanism of an external spinal brace system with cutaway portions.

FIG. 4 depicts a rear view of an enlarged representation of anembodiment of the cut away portions from FIG. 3 .

FIG. 5 depicts a rear view of a representation of an embodiment of firstand second support mechanism of an external spinal brace systemincluding fluid conduits.

FIG. 6 depicts a top view of a representation of an embodiment of afirst support mechanism of an external spinal brace system.

FIG. 7 depicts a rear view of a representation of an embodiment of firstand second support mechanism of an external spinal brace system with cutaway portions.

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof are shown by way ofexample in the drawings and may herein be described in detail. Thedrawings may not be to scale. It should be understood, however, that thedrawings and detailed description thereto are not intended to limit theinvention to the particular form disclosed, but on the contrary, theintention is to cover all modifications, equivalents and alternativesfalling within the spirit and scope of the present invention as definedby the appended claims.

The headings used herein are for organizational purposes only and arenot meant to be used to limit the scope of the description. As usedthroughout this application, the word “may” is used in a permissivesense (i.e., meaning having the potential to), rather than the mandatorysense (i.e., meaning must). The words “include,” “including,” and“includes” indicate open-ended relationships and therefore meanincluding, but not limited to. Similarly, the words “have,” “having,”and “has” also indicated open-ended relationships, and thus mean having,but not limited to. The terms “first,” “second,” “third,” and so forthas used herein are used as labels for nouns that they precede, and donot imply any type of ordering (e.g., spatial, temporal, logical, etc.)unless such an ordering is otherwise explicitly indicated. For example,a “third die electrically connected to the module substrate” does notpreclude scenarios in which a “fourth die electrically connected to themodule substrate” is connected prior to the third die, unless otherwisespecified. Similarly, a “second” feature does not require that a “first”feature be implemented prior to the “second” feature, unless otherwisespecified.

Various components may be described as “configured to” perform a task ortasks. In such contexts, “configured to” is a broad recitation generallymeaning “having structure that” performs the task or tasks duringoperation. As such, the component can be configured to perform the taskeven when the component is not currently performing that task. As such,the component can be configured to perform the task even when thecomponent is not currently on.

Various components may be described as performing a task or tasks, forconvenience in the description. Such descriptions should be interpretedas including the phrase “configured to.” Reciting a component that isconfigured to perform one or more tasks is expressly intended not toinvoke 35 U.S.C. § 112 paragraph (f), interpretation for that component.

The scope of the present disclosure includes any feature or combinationof features disclosed herein (either explicitly or implicitly), or anygeneralization thereof, whether or not it mitigates any or all of theproblems addressed herein. Accordingly, new claims may be formulatedduring prosecution of this application (or an application claimingpriority thereto) to any such combination of features. In particular,with reference to the appended claims, features from dependent claimsmay be combined with those of the independent claims and features fromrespective independent claims may be combined in any appropriate mannerand not merely in the specific combinations enumerated in the appendedclaims.

It is to be understood the present invention is not limited toparticular devices or biological systems, which may, of course, vary. Itis also to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto be limiting. As used in this specification and the appended claims,the singular forms “a”, “an”, and “the” include singular and pluralreferents unless the content clearly dictates otherwise. Thus, forexample, reference to “a linker” includes one or more linkers.

DETAILED DESCRIPTION

Definitions

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art.

The term “connected” as used herein generally refers to pieces which maybe joined or linked together.

The term “coupled” as used herein generally refers to pieces which maybe used operatively with each other, or joined or linked together, withor without one or more intervening members.

The term “directly” as used herein generally refers to one structure inphysical contact with another structure, or, when used in reference to aprocedure, means that one process effects another process or structurewithout the involvement of an intermediate step or component.

The term “elastic” as used herein generally refers to an object ormaterial able to resume its normal shape spontaneously aftercontraction, dilatation, or distortion.

In some embodiments, a system and/or method may include an externalspinal brace system. In some embodiments, the external brace systemapplies a distraction force to the subject. A distraction forceappropriately applied to a subject may overcome abnormal deviations to asubject's spine. This line of reasoning is based at least in part onHueter-Volkmann Law. The Heuter-Volkmann Law states that compressionapplied across a growth plate decelerates growth and that tension acrossa growth plate accelerates growth. This would suggest that applying adistraction force, i.e. tension, to the posterior spine could acceleratethe posterior growth of the spine relative to the anterior spinecounteracting the development of scoliosis. Wolff's law was developed bythe German surgeon Julius Wolff. Wolff's law states that bone in ahealthy person or animal will adapt to the loads under which it isplaced. If loading on a particular bone increases, the bone will remodelitself over time to become stronger to resist that sort of loading. Theinternal architecture of the trabeculae undergoes adaptive changes,followed by secondary changes to the external cortical portion of thebone.

Mechanical deviations of the spine may result from anterior overgrowthof spinal vertebrae relative to a posterior side resulting in suchconditions as scoliosis. In some embodiments, the external brace systemapplies a posterior distraction force to the subject. By applying aposterior distraction force bone growth will be encouraged on theposterior side counteracting the anterior overgrowth. In someembodiments, the same principles could be applied when a subject isexperiencing posterior overgrowth by applying anterior distractionforces. This may allow a subject who employs an external spinal bracesystem as described herein to ameliorate or mitigate spinalabnormalities without using surgery or at least reducing the amount ofsurgical treatments. In some embodiments, an external spinal bracesystem may provide: axial forces (e.g., resulting in lengthening thespine); lateral forces (e.g., resulting in restricting/ while allowinglateral bending within a predetermined amount (allowing more flexibilitythan current braces)); compressive forces; and torsional forces (e.g.,to counteract rotational forces of, for example, scoliosis).

FIG. 1 depicts a rear view of a representation of an embodiment of anexternal spinal brace system 100. FIG. 2 depicts a front view of arepresentation of an embodiment of an external spinal brace system 100.In some embodiments, the system may include a plurality of supportmechanisms 110 including at least first 110 a and second supportmechanisms 110 b. The first support mechanism 110 a may be coupled (ordirectly attached), during use, to the second support mechanism 110 bsuch that the first and second support mechanisms are inhibited fromdecoupling. In some embodiments, the external spinal brace systeminhibits spine curvatures in at least several planes of motioncomprising lateral bending, flexion, extension, rotation, and ultimatelylimiting buckling of spine.

In some embodiments, the support mechanisms may be coupled (or directlyattached) together to allow at least limited movement in a subjectincluding, for example, side bending, twist bending, flexion, and/orextension. In some embodiments, the external spinal brace system 100includes a first coupling portion 120 at a first end 130 of the firstsupport mechanism 110 a. The first support mechanism 110 a may include afirst coupling opening 140 at a second end 150 (e.g., as depicted inFIG. 6 ) of the first support mechanism (wherein the second end isopposite to the first end of the first support mechanism). The externalspinal brace system 100 may include a second coupling portion 160 at athird end 170 of the second support mechanism 110 b. The external spinalbrace system 100 may include a second coupling opening 180 at a fourthend 190 of the second support mechanism 110 b (the fourth end isopposite to the third end of the first support mechanism). The firstcoupling portion of the first support mechanism is positioned, duringuse, in the second coupling opening of the second support mechanism suchthat the first and second support mechanisms are inhibited, during use,from decoupling. FIG. 3 depicts a rear view of a representation of anembodiment of first and second support mechanism 110 a-b of an externalspinal brace system 100 with cut away portions. In FIG. 3 first couplingportion of the first support mechanism is positioned, during use, in thesecond coupling opening of the second support mechanism. FIG. 4 depictsa rear view of an enlarged representation of an embodiment of the cutaway portions from FIG. 3 . Support mechanisms may be formed fromlightweight resilient materials that can stand up to the stresses of useand yet not put unwanted stress on the user due to weight. Supportmechanisms may be formed at least in part from polymers (e.g. carbonfiber), lightweight metals (e.g., titanium), and/or a combinationthereof.

In some embodiments, the first coupling portion 120 may include asubstantially spherical portion 120 a. The second coupling opening 180may include a complementary shape to the spherical portion.Complementary spherical portions may allow for various types of movementwhich may or may not function to mimic normal human movement.Complementary spherical portions may typically function to mimic one ormore types of normal human movement allowed by a healthy spine. Thecoupling may mimic one or more types of normal human movement allowed bya healthy spine while limiting the range of movement in one or moredirections based upon the needs of the particular person. For example, asubject with a spinal abnormality such as kyphosis may limit certainhuman movements which might exacerbate the kyphosis condition. Thecoupling portions control certain movements of the subject based uponthe shapes of the first coupling portion and the second couplingopening. Other means may include stops which limit movement.

In FIGS. 3 and 4 first coupling portion 120 of the first supportmechanism 110 a is positioned, during use, in the second couplingopening 180 of the second support mechanism 110 b. Within the opening aresilient member 200 (e.g., fluid chamber, electric, magnetic, orelectromagnetic based) may be positioned. A bearing member 210 may bepositioned above the resilient member and in some embodiments thebearing member may form a portion of the resilient member. At least oneside of the bearing member may include a surface with a complementarysurface to at least a portion of the first coupling portion (as depictedin FIG. 4 ).

In some embodiments, a locking mechanism 220 may function to inhibitdecoupling of the first coupling portion from the second couplingopening and as such decoupling of the first support mechanism from thesecond support mechanism. The locking mechanism may include a lock ring220. A lock ring is a washer used to prevent components from becomingloose during rotation. In some embodiments, the locking mechanism mayinclude a stop 230 which inhibits movement of the lock ring onceassembled and/or positioned in the second coupling opening. The stop mayinclude an expansion stop ring. The locking mechanism 220 and/or thestop 230 may function together or separate to limit certain types ofmovement of the first support mechanism relative to the second supportmechanism.

In some embodiments, the coupling mechanism may include a resilientmember 200 which provides a positive distraction force between eachsupport mechanism. The force exerted by the resilient member may beadjustable. In some embodiments, the resilient member may include aspring or elastic member. The spring and/or elastic member may beadjusted by switching out members of different resiliency.

In some embodiments, the resilient member may include a fluid chamber200. The fluid may exert a distraction force. The fluid may exert aforce against a movable plate 210. Fluids may include gasses and/orliquids. As such the force exerted by fluid in the fluid chamber may beadjusted by transferring fluids to or from the fluid chamber. The forcemay be adjusted employing different types of gasses and/or liquids. Theforce may be adjusted employing different types of means (e.g.,electromagnetic, magnetic, electric, or mechanical (e.g., screw).

In some embodiments, one or more conduits may be coupled (or directlyattached) to the fluid chamber. A first chamber may be coupled (ordirectly attached) to a fluid source using a conduit 240 (e.g., asdepicted in FIG. 1 ). In some embodiments, each chamber may be coupled(or directly attached) to a fluid source using a conduit 240. In someembodiments, the fluid chambers of an external spinal brace system maybe coupled (or directly attached) to each other using a series ofconduits 250 (e.g., as depicted in FIGS. 1 and 5 such that only a singlefluid chamber needs to be coupled (or directly attached) to a fluidsource which is then directed to other fluid chambers through thedepicted/discussed conduits).

In some embodiments, as fluid is transferred to the fluid chamber whichprovides an expansion force against the bearing member moving thebearing member such that a distance between the first support member andthe second support member is increased and/or applies a positivedistraction force.

FIG. 7 depicts a rear view of a representation of an embodiment of firstand second support mechanisms 110 a-b of an external spinal brace system100 with cut away portions. In some embodiments, as described previouslyherein the first support mechanism 110 a may include a first couplingportion 120 as well as a first and a second engaging members 260 a-b ata first end of the first support mechanism. The first support mechanismmay include a first coupling opening as well as a first and secondopening at the second end of the first support mechanism. The second endmay be opposite to the first end of the first support mechanism. Thesecond support mechanism 110 b may include a second coupling portion 160at a third end of the second support mechanism 110 b. The second supportmechanism 110 b may include a second coupling opening 180 and a thirdand fourth opening 270 a-b at the fourth end of the second supportmechanism 110 b. The fourth end may be opposite to the third end of thesecond support mechanism. The first coupling portion of the firstsupport mechanism may be positioned, during use, in the second couplingopening of the second support mechanism. The first and second engagingmembers of the first support mechanism may be positioned, during use, inthe third and fourth openings respectively of the second supportmechanism.

In the embodiment depicted in FIG. 7 resilient members 200 a-c arepositioned in the second coupling opening 180 and in the third 270 a andfourth 270 b openings respectively of the second support mechanism. Theresilient member which provides a positive distraction force betweeneach support mechanism. The force exerted by the resilient members maybe adjustable. In some embodiments, the resilient member may include aspring or elastic member. In the embodiment depicted in FIG. 7 theresilient members are depicted as springs. In some embodiments, one maybe able to adjust a spring load using, for example, a screw to increasethe load of the spring. In some embodiments, snap rings may be used tokeep springs in and/or connect spinal mechanism units, snap rings mayallow for a maximum limit of the expansion of the spring.

In some embodiments, the external brace system may include at least oneelastic member 280 (e.g., as depicted in FIGS. 1,3,5 ). The elasticmembers may function to control (e.g., limit) side (lateral) bending,twist (rotational) bending, flexion and/or extension. The elasticmembers may be used to assist in correcting abnormal position of asubject's spine. A first elastic member 280 a (e.g., as depicted in FIG.5 ) may couple (or directly attach) a first side 290 of the firstsupport member 110 a to a second side 300 of the second support member110 b. The first side and the second side of the support members may beon the same side of a sagittal plane of the subject. In someembodiments, a second elastic member 280 b (e.g., as depicted in FIG. 5) may couple (or directly attach) a third side 310 of the first supportmember 110 a to a fourth side 320 of the second support member 110 b.The third side and the fourth side of the support members may be on thesame side of a sagittal plane. In some embodiments, the first elasticmember and the second elastic member may be on opposing sides of thesagittal plane.

Elastic members 280 may be coupled (or directly attached) on one or moresides of one or more of the support members. By coupling the members toone side as opposed to another may result in different forces on theexternal brace system and therefore the subject during use. In someembodiments, one or more elastic members are coupled (or directlyattached) to a posterior side of the first and second support members.Coupling the elastic members to a posterior surface of the supportmembers may extend one or more portions of the external brace systemrelative to the wearer. Exerting such a force in such a direction maycounteract certain spinal abnormalities such as, for example,hyperkyphosis. Hyperkyphosis refers to the abnormally excessive kyphoticcurvature of the spine as it occurs in the thoracic spine. Hyperkyphosiscan result from degenerative diseases such as arthritis; developmentalproblems (e.g., Scheuermann's disease); osteoporosis with compressionfractures of the vertebra; tumors or traumatic fractures. In the senseof a deformity, hyperkyphosis is the pathological curving of the spine,where parts of the spinal column lose some or all of their normalprofile. This results in relative forward bending of the spine, it canalso be seen with poor posture. The first elastic member may exert afirst force which is different from a second force of the second elasticmember depending upon the needs of the subject.

In some embodiments, one or more elastic members are coupled (ordirectly attached) to a posterior side of the first and second supportmembers. Coupling the elastic members to an anterior side of the supportmembers may flex one or more portions of the external brace system.Exerting such a force in such a direction may counteract certain spinalabnormalities such as, for example, hyperlordosis. The term lordosisrefers to the normal curvature of the lumbar and cervical regions of thespine in the sagittal plane. Excessive curvature of the lower back inthe sagittal plane is known as lumbar hyperlordosis.

It should be noted that throughout much of the description herein afirst and second support mechanism will be discussed as an example ofpart of a plurality of support mechanisms. There are no real limits onthe number of support mechanisms that may be employed. In fact, atypical example of an external spinal brace system may include about8-20, 12-18, or 15 support mechanisms. The number of support mechanismsmay be determined for each individual as needed. The number of supportmechanisms may be determined by a user's number of vertebral bodies(e.g., 15 vertebral bodies, T1-L5). The number of support mechanisms maybe determined at least in part by the size of the individual supportmechanisms and a length of a subject's torso. The number of supportmechanisms may be adjusted for a subject as needed (e.g., as a subjectgrows support members may be added) to reduce costs, as opposed tohaving to purchase an entirely new external brace system.

In some embodiments, the system may include a coupling system 330 (e.g.,as depicted in FIG. 2 ). The coupling system may couple (or directlyattach) the plurality of support mechanisms 110 to a subject such thatthe plurality of support mechanisms 110 are positioned, during use,along at least a portion of the subject's spine on the surface of thesubject. In some embodiments, the coupling system may include aplurality of elongated members 340 coupled (or directly attached) to theplurality of support mechanisms 110. The plurality of elongated members340 may be coupled (or directly attached) to opposing sides of theplurality of support mechanisms 110. The plurality of elongated membersmay wrap around the subject in order to couple (or directly attach) thesystem to the subject during use. A length of the plurality of elongatedmembers may be adjustable relative to the plurality of supportmechanisms. The length may be adjustable using buckles, loops, etc. Theability to adjust the length may be beneficial for sizing the system foreach individual subject, for making adjustments to forces applied by theelongated members to treatment as a subject's condition changes. It alsoallows for adjustments to accommodate growth of a subject.

In some embodiments, the coupling system may include a fasteningmechanism 350 (e.g., as depicted in FIG. 2 ). The fastening mechanism350 may function to couple (or directly attach) a first portion 340 a ofthe plurality of elongated members to a second portion 340 b of theplurality of elongated members (e.g., as depicted in FIG. 2 ). The firstportion 340 a of the plurality of elongated members may be coupled (ordirectly attached) to a first side of the support mechanisms while thesecond portion 340 b of the plurality of elongated members may becoupled (or directly attached) to an opposing second side of the supportmechanisms (e.g., as depicted in FIG. 1 ). In some embodiments, thefastening mechanism may include a zipper, latches, hooks, lacing, hookand loop, snaps, or a combination thereof.

In some embodiments, the system may include one or more couplingelongated members 360 (e.g., similar to a belt) which functions tocouple (or directly attach) the system to a subject during use. Thecoupling elongated members may function to assist in positioning thesystem relative to the subject during use. An upper elongated member 360a (e.g., as depicted in FIGS. 1-2 ) may function to couple (or directlyattach) the system to an upper portion of a subject. The upper elongatedmember may be positioned under a subject's armpits or below thesubject's shoulder blades. A lower elongated member 360 b (e.g., asdepicted in FIGS. 1-2 ) may function to couple (or directly attach) thesystem to a lower portion of a subject. The lower elongated member maybe positioned at a subject's waist at and/or above the subject's pelvis.The coupling elongated members may be formed from substantially flexibleand/or rigid materials. In some embodiments, the upper elongated memberis positioned, during use, around an upper portion of the subject'storso and the lower elongated member is positioned, during use, around alower portion of the subject's torso.

In some embodiments, the external spinal brace system providesprogressive compressive forces on the ribs for indirect spinecorrection. Much of the compressive force may be applied by theplurality of elongated members during use. The elongated members may bewrapped around the subject such that as they are tightened (e.g.,through use of buckles, adjustment mechanisms, etc.) they exert acompressive force on the subject. The elongated members may provide acompressive force as the support members are separated in order toprovide an axial force. In some embodiments, the elongated members maybe attached to the support members such that they are oriented downtoward a lower portion of the torso (e.g., the pelvis as depicted inFIG. 1 ), while the support members are attached to the fasteningmechanism such that they are oriented up toward an upper portion of thetorso (e.g., the shoulder blades as depicted in FIG. 2 ).

In some embodiments, the external spinal brace system may include bonestimulators which encourage bone growth. Bone stimulators may encourageposterior spinal growth. Bone stimulators may be incorporated directlyinto the external spinal brace system (e.g., the support members). Avariety of biological, mechanical, and physical interventions have beendeveloped to enhance bone growth and fracture healing. There exist arange of physical methods to stimulate bone healing including electricalstimulators, low-intensity pulsed ultrasound, and extracorporeal shockwaves. These modalities are less invasive to patients and the cost orcomplications related to harvesting an autograft are eliminated or atleast reduced.

Electrical and electromagnetic (EM) fields are assumed to play a role inbone healing through the same principles as mechanical stressapplications. When mechanical load is applied to bone, a strain gradientdevelops as with Wolff's law. Application of EM to the fracture site ismeant to mimic the effect of mechanical stress on bone. A variety ofinstruments have been are used to deliver electrical and EM fields tofracture sites, including: invasive direct-current (DC) stimulators,noninvasive capacitive coupling (CC) stimulators, and noninvasiveinductive coupling (IC) stimulators. The advantages of electricalstimulation may include the low complication rates as compared to otherinvasive methods. In vitro studies suggest that ultrasonic stimulationenhances bone healing by increasing the incorporation of calcium ions incultures of cartilage and bone cells and stimulate the expression ofnumerous genes involved in the healing process. Extracorporeal shockwaves (ESWT) have been studied as well for treating bone fractures.

In some embodiments, the external spinal brace system may harness humanmovement for energy generation for use in the external spinal bracesystem or for use by other systems. Human movement may be used forenergy generation which may be used to power one or more systems of theexternal brace system and/or stored (e.g., in a rechargeable battery)for later use by one or more external system which are and/or are notassociated with the external brace system.

In some embodiments the brace may be used to collect biomechanical datarelated to human movement and the spine including but not limited tomagnitude and force of motion in all planes of movement.

In this patent, certain U.S. patents, U.S. patent applications, andother materials (e.g., articles) have been incorporated by reference.The text of such U.S. patents, U.S. patent applications, and othermaterials is, however, only incorporated by reference to the extent thatno conflict exists between such text and the other statements anddrawings set forth herein. In the event of such conflict, then any suchconflicting text in such incorporated by reference U.S. patents, U.S.patent applications, and other materials is specifically notincorporated by reference in this patent.

Further modifications and alternative embodiments of various aspects ofthe invention will be apparent to those skilled in the art in view ofthis description. Accordingly, this description is to be construed asillustrative only and is for the purpose of teaching those skilled inthe art the general manner of carrying out the invention. It is to beunderstood that the forms of the invention shown and described hereinare to be taken as the presently preferred embodiments. Elements andmaterials may be substituted for those illustrated and described herein,parts and processes may be reversed, and certain features of theinvention may be utilized independently, all as would be apparent to oneskilled in the art after having the benefit of this description of theinvention. Changes may be made in the elements described herein withoutdeparting from the spirit and scope of the invention as described in thefollowing claims.

What is claimed is:
 1. An external spinal brace system comprising: afirst support mechanism comprising: (a) first and second halves thatoppose each other, (b) a first coupling portion in the first half, and(c) first, second, and third openings; a second support mechanism, whichis separably coupled to the first support mechanism, comprising: (a)additional first and second halves that oppose each other, (a) a secondcoupling portion in the additional first half; and (b) a fourth, fifth,and sixth openings; first and second resilient members removablyincluded respectively in the second and third openings and third andfourth resilient members removably included respectively in the fifthand sixth openings; and at least one strap to position the first andsecond support mechanisms along a portion of a subject's spine such thatthe first and second support mechanisms apply a posterior distractionforce to the subject.
 2. The system of claim 1, wherein the secondcoupling portion is at least partially included in the first opening. 3.The system of claim 2, wherein the first and third resilient members areon a same side of a sagittal plane.
 4. The system of claim 3, whereinthe first, second, and third openings are in the second half and thefourth, fifth, and sixth openings are in the additional second half. 5.The system of claim 4, wherein: the external spinal brace system is aspinal distraction system; the at least one strap is to position thefirst and second support mechanisms along a posterior portion of thesubject's spine such that the first and second support mechanisms applytension to the posterior portion of the subject's spine.
 6. The systemof claim 3, wherein: the first resilient member exerts a firstdistractive force and the second resilient member exerts a seconddistractive force; the first distractive force is unequal to the seconddistractive force.
 7. The system of claim 2, wherein the first andsecond resilient members are on opposing sides of a sagittal plane. 8.The system of claim 2 comprising a third coupling portion, wherein thethird coupling portion is at least partially included in the fourthopening.
 9. The system of claim 8, wherein at least a subportion of thesecond coupling portion is spherical and at least a subportion of thethird coupling portion is spherical.
 10. The system of claim 8, whereinthe first and second support mechanisms are resiliently coupled to eachother via the first and second resilient members.
 11. The system ofclaim 8 comprising a third support mechanism, wherein the second andthird support mechanisms are resiliently coupled to each other via thethird and fourth resilient members.
 12. An external spinal brace systemcomprising: a first support mechanism comprising: (a) first and secondhalves that oppose each other, (b) a first coupling portion in the firsthalf, and (c) first, second, and third openings in the second half; asecond support mechanism, which is separably coupled to the firstsupport mechanism, comprising: (a) additional first and second halvesthat oppose each other, (a) a second coupling portion in the additionalfirst half; and (b) a fourth, fifth, and sixth openings in theadditional second half; first and second rods removably includedrespectively in the second and third openings and third and fourth rodsremovably included respectively in the fifth and sixth openings; and atleast one strap to position the first and second support mechanismsalong a portion of a subject's spine such that the first and secondsupport mechanisms apply a posterior distraction force to the subject.13. The system of claim 12, wherein the second coupling portion is atleast partially included in the first opening.
 14. The system of claim13 comprising a third coupling portion, wherein the third couplingportion is at least partially included in the fourth opening.
 15. Thesystem of claim 14, wherein at least a subportion of the second couplingportion is spherical and at least a subportion of the third couplingportion is spherical.
 16. The system of claim 14, wherein the first andsecond support mechanisms are resiliently coupled to each other via thefirst and second rods.
 17. The system of claim 14 comprising a thirdsupport mechanism, wherein the second and third support mechanisms areresiliently coupled to each other via the third and fourth rods.
 18. Thesystem of claim 13, wherein the first and third rods are on a same sideof a sagittal plane.
 19. The system of claim 18, wherein: the externalspinal brace system is a spinal distraction system; the at least onestrap is to position the first and second support mechanisms along aposterior portion of the subject's spine such that the first and secondsupport mechanisms apply tension to the posterior portion of thesubject's spine.
 20. The system of claim 13, wherein the first andsecond rods are on opposing sides of a sagittal plane.